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The investigational product (ZTL-103) was a formulation of 10 mg THC/10 mg CBD per ml oral solution. The product was manufactured under supervision of the trial sponsor by Replek Farm, Macedonia in accordance with Good Manufacturing Practice (GMP), International Council for Harmonisation-GMP (ICH-GCP), and local regulatory requirements. The product was packaged into ready-to-use pre-filled syringes by Suda Pharmaceuticals (Australia), under GMP conditions.

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The study was conducted in accordance with the Helsinki Declaration of 1994 and subsequent amendments. The trial was prospectively registered with the Australian New Zealand Clinical Trials Register (CT-2019-CTN-01224-1). Eligible participants were aged over 25 years with CNCP, on long-term treatment (at least 12 months) with high dose (oral morphine equivalent daily dose [OMEDD] ≥ 60 mg) opioid analgesia.

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Participants were recruited at two sites, a public hospital pain management clinic and at a community medicinal cannabis clinic. Eligibility screening, informed consent, and baseline assessment were conducted by a member of the research team. Inclusions: aged over 25 years of age; patients with CNCP on long-term treatment (at least 12 months) receiving high dose (OMEDD > 60 mg) opioid analgesia; willing to cease driving a motor vehicle for the duration of the study; willing to undertake fasting requirements and meal restrictions whilst providing blood samples for pharmacokinetic studies; agree to undergo all assessments for trial duration of 5 weeks including blood testing for pharmacokinetic analysis; psychometrics and a saliva swab for a drug screen; no cannabis use in previous month, as confirmed by a negative drug screen.

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Pharmacokinetic studies are typically conducted in healthy controls. Persons with CNCP often have multiple physical comorbidities and are prescribed multiple medications. This study was conducted in a “real world” cohort which necessitated decisions regarding limitations on prior and concomitant treatments and/or drug interactions. THC induces CYP1A2 activity and reduces serum concentrations of drugs metabolized by CYP1A2, e.

anti-psychotic medications such as clozapine, olanzapine, haloperidol, and chlorpromazine [20]. Thus persons with psychosis were excluded from this study. Serum concentrations of duloxetine and naproxen may be reduced with concomitant use of THC: persons on these drugs were eligible for recruitment but were required to be monitored for drug interactions.

Tramadol metabolism is primarily mediated through CYP2D6, CYP3A4, and CYP2B6 [21]. Carbamazepine is a potent inducer of CYP3A4, and CBD may inhibit its metabolism resulting in increased serum concentrations. Serum concentrations of topiramate have also been observed to rise with increasing CBD dose but changes have been reported to be within the accepted therapeutic range [22].

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Current use of valproate was an exclusion for the current study as this combination may elevate aspartate transaminase (AST) and/or alanine aminotransferase (ALT) concentrations [23]. Benzodiazepines were excluded because of potential excessive sedation in combination with the investigational product (ZTL-103). No new medication other than the investigational product, opioid medications for CNCP, and contraceptives was permitted to be commenced after initiation on to the trial.

The pharmacokinetics were investigated on day 1 after a single dose of 2. 5 mg THC/2. 5 mg CBD after fasting for 12 h, day 8 after a single dose of 2. 5 mg THC/2. 5 mg CBD following a high fat meal, day 15 after a single dose of 5 mg THC/5 mg CBD after twice daily 2.

5 mg CBD for 7 days, day 22 after a single dose of 7. 5 mg THC/7. 5 mg CBD after twice daily 5 mg THC/5 mg CBD for 7 days, and day 29 after a single dose of 12. 5 mg THC/12. 5 mg CBD after twice daily 7.

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5 mg CBD for 7 days. Participants returned for final assessments on day 36, after a 7-day washout period; however, no bloods were taken on this day as it was not anticipated that there would be any THC or CBD 1 week after a single dose of 12. 5 mg THC/12.

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As an indication of this a single dose of 12. 5 mg THC/12. 5 mg CBD was given the previous evening at 4 pm prior to the day 29 pharmacokinetic (PK) analysis. The concentrations of THC and CBD in the predose sample approximately 20 h later were generally around 0.

Thus it would be highly unlikely that after a single dose of 12. 5 mg THC/12. 5 mg CBD there would be detectable THC and CBD 148 h later. To explore secondary objectives, participants completed the Brief Pain Inventory (BPI) [24] which has two subscales, namely pain severity and pain interference (i.

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how pain impacts function and daily life), and recorded opioids, other analgesics, and any other medications, daily. At each visit to the study site (days 1, 8, 15, 22, 29, 36) participants completed the Depression, Anxiety, and Stress Scale (DASS-21) [25], Insomnia Severity Index (ISI) [26], and underwent a physical examination by a clinician.